Substance Use Treatment and Access to Resources (STARS) Project

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT04459000
Status
Recruiting
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Conditions

  • Child Neglect
  • Pregnancy Related
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
N/A - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • STARS + maternal Attachment Biobehavioral Catchup home visiting model — BEHAVIORAL
    Mothers receive up to 12 home visits from a licensed therapist focused on attachment and positive parenting in substance exposed babies. This includes 1 prenatal home visit and up to 11 postnatal visits.
  • STARs Only — BEHAVIORAL
    Participants receive prenatal care in the STAR clinic (a clinic specifically designed to support mothers with substance abuse who are at risk of losing their children to child welfare at birth).

Study Details

This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.

Key Dates

Start date
Dec 16, 2020
Status verified
Oct 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: STARs Only
    Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.
  • Experimental: STARS + mABC
    Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.
  • No Intervention: Control Group/CHOUM Only
    These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

Primary Outcome Measure

Mother substance use [ Time Frame: Change from baseline to 18 months post birth of child ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73117
Mallory Ford
[email protected]
405-271-8858
Geneva marshall
[email protected]
405-2718858

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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